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Stringent Particularity Requirement of the Rule 9(B) Pleading Standard As a Critical Bar to Off- Label Promotion Fraud Whistleblowers

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Stringent Particularity Requirement of the Rule 9(B) Pleading Standard As a Critical Bar to Off- Label Promotion Fraud Whistleblowers CHEN.36.1.7 (Do Not Delete) 10/27/2014 4:50 PM DEPRESSING DIAGNOSIS: STRINGENT PARTICULARITY REQUIREMENT OF THE RULE 9(B) PLEADING STANDARD AS A CRITICAL BAR TO OFF- LABEL PROMOTION FRAUD WHISTLEBLOWERS Emily T. Chen† TABLE OF CONTENTS INTRODUCTION .................................................................................................................334 I. BACKGROUND ............................................................................................................340 A. False Claims Act ............................................................................................340 B. Federal Food, Drug, and Cosmetic Act and Off-Label Promotion ..........348 C. Off-Label Promotion Liability and Medicaid Fraud Under the False Claims Act ......................................................................................................351 II. ANALYSIS ....................................................................................................................353 A. Rule 9(b) and the Particularity Requirement ............................................353 B. The Allison Engine Standard and Congressional Response ....................355 C. The First Circuit’s Approach ........................................................................358 D. The Eleventh Circuit’s Approach .................................................................361 III. PROPOSAL ...................................................................................................................363 A. Congressional Intent and Public Policy Favor the Application of a Lowered Rule 9(b) Pleading Standard to Off-Label Promotion Cases ....363 B. Rationale Supporting the Heightened Burden of Proof Under the Clear and Convincing Standard ..................................................................365 CONCLUSION......................................................................................................................367 † Executive Editor, Cardozo Law Review. J.D. Candidate (June 2015), Benjamin N. Cardozo School of Law; B.A., Barnard College, Columbia University, 2010. I would like to thank Professor Richard A. Bierschbach for his invaluable guidance; Matt Weston, Marisa Seiss, Jonathan Raz, and the editors of the Cardozo Law Review for their insightful advice and diligence; my parents, Jack and Helen, for their boundless love and support; and my brother, Dennis, for his unwavering humor and encouragement. 333 CHEN.36.1.7 (Do Not Delete) 10/27/2014 4:50 PM 334 CARDOZO LAW REVIEW [Vol. 36:333 INTRODUCTION The False Claims Act1 (FCA) is the federal government’s primary tool for combating fraud against the government, and it has proven invaluable as a recovery mechanism since its enactment during the Civil War.2 In fact, between 2000 and 2013, the United States recovered over $8.8 billion dollars from pharmaceutical companies alone in civil settlement agreements arising from off-label promotion cases brought 4 under the FCA.3 In light of recent Supreme Court decisions, off-label 1 31 U.S.C. §§ 3729–3733 (2012). 2 See discussion infra Part I.A. 3 Brian C. Elmer, False Claims Act Settlements 2000–2014, CROWELL & MORING LLP (July 25, 2014), http://www.crowell.com/files/false-claims-act-fca-settlements-crowell-moring.pdf. Indeed, federal recoveries from the combined civil and criminal settlements amounted to over $15.5 billion dollars within the same period. See id.; Barry Meier, In Guilty Plea, OxyContin Maker to Pay $600 Million, N.Y. TIMES, May 10, 2007, http://www.nytimes.com/2007/05/10/business/ 11drug-web.html?pagewanted=all&_r=0; Press Release, Dep’t of Justice, Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-Label Promotion of Depakote (May 7, 2012); Press Release, Dep’t of Justice, Allergan Agrees to Plead Guilty & Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox® (Sept. 1, 2010); Press Release, Dep’t of Justice, Amgen Inc. Pleads Guilty to Fed. Charge in Brooklyn, NY; Pays $762 Million to Resolve Criminal Liab. & False Claims Act Allegations (Dec. 19, 2012); Press Release, Dep’t of Justice, Biopharm. Co., Cephalon, to Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Mktg. (Sept. 29, 2008); Press Release, Dep’t of Justice, Biopharm. Firm Intermune to Pay U.S. Over $36 Million for Illegal Promotion & Mktg. of Drug Actimmune (Oct. 26, 2006); Press Release, Dep’t of Justice, Boehringer Ingelheim to Pay $95 Million to Resolve False Claims Act Allegations (Oct. 25, 2012); Press Release, Dep’t of Justice, Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Mktg. & Pricing (Sept. 28, 2007); Press Release, Dep’t of Justice, Danish Pharm. Novo Nordisk to Pay $25 Million to Resolve Allegations of Off-Label Promotion of Novoseven (June 10, 2011); Press Release, Dep’t of Justice, Drug Maker Forest Pleads Guilty; To Pay More Than $313 Million to Resolve Criminal Charges & False Claims Act Allegations (Sept. 15, 2010); Press Release, Dep’t of Justice, Eli Lilly & Co. Agrees to Pay $1.415 Billion to Resolve Allegations of Off-Label Promotion of Zyprexa (Jan. 15, 2009); Press Release, Dep’t of Justice, GlaxoSmithKline to Plead Guilty & Pay $3 Billion to Resolve Fraud Allegations & Failure to Report Safety Data (July 2, 2012); Press Release, Dep’t of Justice, ISTA Pharm. Inc. Pleads Guilty to Fed. Felony Charges; Will Pay $33.5 Million to Resolve Criminal Liab. & False Claims Act Allegations (May 24, 2013); Press Release, Dep’t of Justice, Johnson & Johnson Subsidiary Scios Pleads Guilty to Misbranding Heart Failure Drug Natrecor (Oct. 5, 2011); Press Release, Dep’t of Justice, Justice Dep’t Announces Largest Health Care Fraud Settlement in Its History (Sept. 2, 2009); Press Release, Dep’t of Justice, Kos Pharm. to Pay More Than $41 Million to Resolve Kickback & Off-Label Promotion Allegations (Dec. 7, 2010); Press Release, Dep’t of Justice, Medicis Pharm. to Pay U.S. $9.8 Million to Resolve False Claims Allegations (May 8, 2007); Press Release, Dep’t of Justice, Novartis Pharm. Corp. to Pay More Than $420 Million to Resolve Off-Label Promotion and Kickback Allegations (Sept. 30, 2010); Press Release, Dep’t of Justice, Novartis Vaccines & Diagnostics to Pay More Than $72 Million to Resolve False Claims Act Allegations Concerning TOBI (May 4, 2010); Press Release, Dep’t of Justice, Otsuka to Pay More Than $4 Million to Resolve Off-Label Mktg. Allegations Involving Abilify (Mar. 27, 2008); Press Release, Dep’t of Justice, Par Pharm. Pleads Guilty & Agrees to Pay $45 Million to Resolve Civil & Criminal Allegations Related to Off-Label Mktg. (Mar. 5, 2013); Press Release, Dep’t of Justice, Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use (Dec. 12, 2012); Press Release, Dep’t of Justice, Pharm. Cos. to Pay $214.5 Million to Resolve Allegations of Off-Label Promotion of Zonegran (Dec. 15, 2010); Press Release, Dep’t of Justice, Pharm. Giant AstraZeneca to Pay $520 Million for Off-Label Drug Mktg. (Apr. CHEN.36.1.7 (Do Not Delete) 10/27/2014 4:50 PM 2014] DEPRESSING DIAGNOSIS 335 promotion cases are more important than ever in ensuring that pharmaceutical companies, particularly generic manufacturers, abide by the FDA’s requisite safety and effectiveness standards5 and that plaintiffs are protected against generic pharmaceuticals where their recourse is greatly limited.6 The Supreme Court’s denial of certiorari in FCA7 cases concerning Rule 9(b) of the Federal Rules of Civil Procedure8 has effectively left the circuits split over the specificity with which a private party alleging off- 27, 2010); Press Release, Dep’t of Justice, Pharm. Giant, Serono, Agrees to Pay $44.3 Million to Settle False Claims Act Case (May 4, 2011); Press Release, Dep’t of Justice, Schering to Pay $435 Million for the Improper Mktg. of Drugs & Medicaid Fraud (Aug. 29, 2006); Press Release, Dep’t of Justice, Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax (Apr. 29, 2010); Press Release, Dep’t of Justice, U.S. Pharm. Co. Merck Sharp & Dohme to Pay Nearly One Billion Dollars Over Promotion of Vioxx® (Nov. 22, 2011); Press Release, Dep’t of Justice, U.S. Subsidiary of Belgian Pharm. Mfr. Pleads Guilty to Off- Label Promotion; Co. to Pay More Than $34 Million (June 9, 2011); Press Release, Dep’t of Justice, Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liab. Relating to Off-Label Promotion (May 13, 2004); Press Release, Dep’t of Justice, Wyeth Pharm. Agrees to Pay $490.9 Million for Mktg. the Prescription Drug Rapamune for Unapproved Uses (July 30, 2013). The Department of Justice (DOJ) may prosecute criminal false claims lawsuits against individuals or entities that defraud the government under 18 U.S.C. § 287, which provides that: Whoever makes or presents to any person or officer in the civil, military, or naval service of the United States, or to any department or agency thereof, any claim upon or against the United States, or any department or agency thereof, knowing such claim to be false, fictitious, or fraudulent, shall be imprisoned not more than five years and shall be subject to a fine in the amount provided in this title. 18 U.S.C. § 287 (2012). For the purposes of this Note, however, references to the FCA strictly encompass the civil provisions, as set forth in 31 U.S.C. §§ 3729–3733, and not the criminal provisions set forth in 18 U.S.C. § 287. 4 See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (holding
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